Healthy Skepticism Library item: 6180

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Publication type: Journal Article

Sedgeworth J, Derewlany L.
Institution/investigator-initiated clinical trials in Canada.
Can J Clin Pharmacol 2006 Sum; 13:(2):e236-9

Abstract:

Institution/investigator-initiated clinical trials in Canada require adherence to similar regulations and processes required of large pharmaceutical manufacturers. This may require an investigator to file a Clinical Trial Application. This article outlines the responsibilities and actions that are required prior to, during, and after the conduct of an institution/investigator initiated trial.

Keywords:
Canada Clinical Trials Data Monitoring Committees Drug Industry/methods Drug Industry/standards* Health Facilities/standards* Humans Randomized Controlled Trials/methods Randomized Controlled Trials/standards* Research Personnel/standards*